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A Myeloablative Conditioning Regimen and Total Body Irradiation Followed by the Transplantation for Patients With Hematological Malignancy

NCT00597519 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2016-02-12

Study results available
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Summary

In this study two cord blood collections will be used to increase the number of cord blood cells you will receive on transplant day. We call this a "double unit" cord blood transplant. A previous study suggests double unit cord blood transplant may have a better result. The main purpose of this study is to find out how good a cord blood transplant using two cord blood collections from two different babies is at curing you of your cancer. Double unit cord blood transplants are now being studied as a way to increase the number of cord blood cells given to bigger children and adult patients.

Based on studies that have already been done double unit cord blood transplant appears to be safer than if only one cord blood unit is used. However, double unit cord blood transplant is a fairly new form of treatment.

Conditions

Interventions

DRUG

Fludarabine, Cyclophosphamide

Fludarabine 25 mg/m2/day IV in the morning x 3 days (days -7, -6 and -5) for a total dose of 75 mg/m2 followed by Cyclophosphamide on days -6 and -5. 60mg/kg/day IV over 30-60 minutes x 2 days (days -6 and -5). High volume fluids should commence approximately 12 hours prior to drug and continue until 24 hours after second dose. Total Body Irradiation: 125 cGy x 11 doses (TID on days -3, -2, -1 and BID on day 0) for a total TBI dose of 1375 cGy. Pediatric patients unable to tolerate a TID dosing schedule can receive 150 cGy x 8 doses (BID on days -3, -2, -1, and 0). All patients will receive GVHD prophylaxis with 2 drugs: Cyclosporine A and Mycophenolate mofetil (MMF). Units should be given consecutively each over approximately 10-30 minutes.Pre-medication should include acetaminophen and diphenhydramine or hydroxyzine.G-CSF 5 mcg/kg/day IV/SQ (dose rounded to vial size to a maximum of 480 mcg) will be given from day +1 until ANC recovery.

PROCEDURE

Transplantation

The UCB ( Umbilical Cord Blood) collection known as a unit is processed to remove excess plasma and red cells, tested for sterility, HLA-typed, cryopreserved and stored. This protocol involves the administration of two UCB units from two different donors. The units will be thawed in the Cytotherapy Laboratory as per the current standard operating procedure.

Sponsors & Collaborators

Principal Investigators

  • Juliet Barker, MBBS · Memorial Sloan Kettering Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
4 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-03-31
Primary Completion
2015-09-30
Completion
2015-09-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00597519 on ClinicalTrials.gov